Program Overview
This one-day intensive workshop equips managers and audit-facing professionals with practical insights and simulations to handle FDA inspections confidently. Led by a senior FDA audit expert, the program blends case studies, role plays, and a mock audit drill to maximize impact in limited time.
Features
- Recognize and avoid common FDA audit pitfalls
- Strengthen data integrity and documentation practices
- Improve confidence in handling investigator interactions
- Experience a mini mock audit to identify gaps
Target audiences
- QA/QC Managers, RA professionals, Audit Coordinators, Plant QA leads.
Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- FDA Inspection Lifecycle4
- Data Integrity & Documentation4
- Handling Investigator Questions4
- Mock Audit Simulation4
- Corrective Action Planning4
Instructor
